Aerial view of the 91次元 campus and buildings around UM's Oval in Missoula, MT.

Research Compliance and Tech Transfer

Investigating Animal Welfare Concerns and Noncompliance

Number: IACUC-POL-031 

Responsible Office: Office of Research and Creative Scholarship (ORCS)

Applies to: This policy is applicable to all animal activities, including wildlife field studies, conducted under the auspices of the University, and applies to all locations under the purview of the UM IACUC. 

1. Purpose

In accordance with federal policy and law (i.e., and AWAR), organizations with an animal care and use program (ACUP) must establish an Institutional Animal Care & Use Committee (IACUC) and authorize it to oversee the ACUP. 

The same standards require the IACUC to provide ongoing oversight for animal activities conducted at the institution. This policy describes the process that the UM IACUC will follow when investigating reports and allegations of noncompliance or welfare concerns relating to the care and/or use of vertebrate animals and/or cephalopods. 

2. Background 

The 91次元’s Animal Care & Use Program (ACUP) adheres to the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (), the federal Animal Welfare Act and Regulations (), the Guide for the Care and Use of Laboratory Animals (), and all other applicable standards.  

Individuals utilizing live or dead vertebrate animals and/or cephalopods under the auspices of the 91次元 (UM) must adhere to these standards any time vertebrate animals and/or cephalopods are used for research, teaching, demonstration, and testing. 

Violations of these standards could impact the ACUP and the University in a variety of ways, including: 1) jeopardize UM’s privilege of using animals in research, instruction, and testing activities, 2) negatively affecting UM’s eligibility to receive grants that include animal use and activities; 3) resulting in monetary penalties (i.e., fines); and 4) leading to public accusations of inhumane treatment of animals.   

3. Definitions

  • Adverse Event: An unexpected incident that leads to harm or endangers the well-being of animals and/or humans. 
  • Allegation: A report that is potentially an incident of noncompliance (e.g., a violation of regulation or IACUC policy), and has not yet been investigated by the IACUC. 
  • Inquiry: The inquiry is an official period used to collect information associated with a report. The purpose is to gather information pertaining to the report that will be used during the IACUC assessment. 
  • Investigation: A formal development of a factual record and the examination of that record leading to a decision to determine, for example, whether noncompliance occurred. During the investigation, the IACUC also quantifies the significance of the incident and identifies the appropriate corrective actions to be taken. 
  • Report: Reports are verbal or written notices of concern relating to aspects of the UM Animal Care & Use Program. Reports are not limited to allegations of noncompliance and may be associated with, for example, an adverse event. 
  • Serious Noncompliance: Serious noncompliance is any noncompliant event that has a negative impact on the welfare of an animal and/or human, and/or is in direct conflict with federal standards governing animal activities, including provisions of the Occupational Health and Safety Program.  
  • Respondent: The person against whom an allegation is directed or who is the subject of animal welfare or noncompliance proceeding. 
  • Complainant: The person who initiates a formal animal welfare or noncompliance complaint. 

4. Process for Reporting Animal Welfare Concerns 

Information for reporting animal welfare concerns will be posted at the main entrance of all 91次元 animal facilities and on the UM website. A complainant may remain anonymous.  

Any individual who has a concern regarding the care and use of animals in research or teaching at UM should voice that concern by any of the following mechanisms: 

  • Contact any member of the 91次元 IACUC, Laboratory Animal Resources staff, Attending Veterinarian, or Institutional Official (IO).  
  • Submit an electronic Animal Welfare Concern Form 
  • Contact , an anonymous compliance reporting system, toll-free 855-753-0486, or through the link. 

Consistent with Montana Board of Regents Whistleblower Policy 211, retaliation or discrimination against any individual who reports a concern or violation related to Laboratory Animal Resources (LAR) or IACUC standards, procedures, rules, or protocols is strictly prohibited. Likewise, individuals who are the subject of a complaint—or who are otherwise involved in the reporting or review process—are prohibited from engaging in reprisals of any kind.  

Any act of retaliation or reprisal in the context of an IACUC-related concern or complaint constitutes a violation of UM and IACUC standards and may result in the loss of privileges and/or access to LAR facilities under UM IACUC oversight. Confidentiality of the complaint and all associated procedures will be respected by all parties involved.  

5. Allegations and Reports

Individual allegations and reports submitted to the IACUC for investigation through, for example, the Animal Welfare Concern Form, Ethics Point, the IACUC Manager, Attending Veterinarian (AV), or the IACUC Chair, are routed to Office of Research and Creative Scholarship (ORCS). ORCS and the IACUC Chair, in consultation with relevant subject matter experts, will determine if an allegation is credible and meets the definition of serious noncompliance.  

The IACUC Chair, Institutional Official, IACUC Manager, and or the AV will take immediate action to ensure the welfare of any animal or human associated with the allegation. This action may include the immediate suspension of animal activities and or an individual’s ability to conduct animal activities until, at minimum, an investigation is conducted. 

An inquiry process is initiated if:  

  • The allegation was made in good faith. 
  • The alleged conduct affects animal welfare and or meets the definition of serious noncompliance. 
  • The allegation is sufficiently credible and specific to identify potential animal welfare issues and/or evidence of noncompliance. 

If an inquiry is unwarranted, a summary of the findings and rationale is communicated to the IACUC.   

6. Inquiry Process Animal Welfare Allegations and Concern:

The purpose of the inquiry is not to reach a conclusion about whether animal welfare issues and or noncompliance occurred or who was responsible but is a process of gathering information and initial fact-finding to determine whether an allegation or animal welfare issue warrants an investigation. An investigation is warranted if (1) there is a reasonable basis for concluding that the allegation affects animal welfare and (2) preliminary information-gathering and preliminary fact-finding from the inquiry indicates that the allegation may have substance. 

The IACUC Chair may appoint a subcommittee to conduct the initial assessment of an allegation or Animal Welfare Concern. Members with direct involvement or conflict of interest with the reported incident will not be appointed.  

7. Notification of Respondent

The IACUC Chair will inform the respondent that an allegation of animal welfare concern has been made against them, provide the respondent with a written summary of the allegation, and explain the investigation process for addressing the allegation. The IACUC Chair will make reasonable efforts to notify the respondent of the allegation in a face-to-face meeting, which generally will be attended by a representative of the Dean’s office.  

8. Investigation of Suspected Animal Welfare Concerns

If an investigation is warranted, ORCS and the IACUC Chair will investigate the concern and or appoint an IACUC subcommittee as an investigation team and an investigation team lead, as appropriate; members with direct involvement or conflict of interest with the reported incident will not be appointed.  

  1. The investigation will include reviewing the initial documentation of concern, interviewing involved personnel, observing the animals, housing and experimental environment, reviewing any pertinent records with appropriate subject matter experts, as applicable to the reported concern. 
  2. An investigation report will be prepared and submitted with findings and recommended corrective/preventative actions to the IACUC Chair. Recommended corrective/preventative actions will apply only to operational processes and procedures. Personnel-related corrective action will not be captured through this procedure. In this case, Human Resources and/or Legal Counsel will be contacted by ORCS. Upon acceptance of the investigation report, the IACUC Chair will review the report, and its recommended actions with the IACUC at a convened meeting. The report is finalized through a motion and a vote of a quorum. 

When the investigation deems that animal welfare has been affected and or noncompliance has occurred with university policies or federal regulations, the report shall include:  

  1. A summary of the records and evidence reviewed during the investigation. 
  2. Identification of university policies or federal violations under which noncompliance occurred. 
  3. A description of the noncompliance violation and whether the violation resulted in any adverse events. 
  4. Corrective actions to be implemented to avoid animal welfare issues and/or noncompliance in the future and a reasonable date by which the corrective actions will be implemented. 

9. Formal Determination of Noncompliance Notification

When the IACUC determines that a violation of university policies or federal regulations has occurred, the IACUC Chair will notify the involved individual(s) in writing of the noncompliance violation and the required corrective actions. In cases where noncompliance is ongoing and represents an animal welfare or safety issue, the IACUC can suspend the research activity. If corrective actions are required, the individual(s) will have a timeline to implement the corrective actions. The individual(s) will have the opportunity to work with the IACUC and the IACUC Chair to modify the corrective actions if deemed appropriate by the IACUC. The Institutional Official, Office of the Provost and the PI’s Department Head, College Dean, and the Office of Sponsored Programs may be notified of the noncompliance violation. 

10. Reporting Noncompliance

ORCS will provide a full explanation of the circumstances and actions to reporting agencies as applicable. 

11. Record Keeping 

The IACUC Manager will keep all records of complaints, violations, investigations, action plans and outcomes on file for a minimum of 3 years. 

12. References

  1. Animal Welfare Act Regulations (AWAR) – 9 CFR Subchapter A, including §2.31 
  2. PHS Policy on Humane Care and Use of Laboratory Animals (2015) 
  3. Guide for the Care and Use of Laboratory Animals, 8th Edition (NRC, 2011) 
  4. OLAW: Guidance on Prompt Reporting to OLAW under PHS Policy 
  5. AAALAC International: Accreditation Program Expectations – Reportable Items 
  6. Montana Board of Regents Policy 211: Whistleblower Protection 

13. Review, Approval and Version History

Policy approval/version information

Version 

Date 

Description of Changes 

Approved By 

1.0 

July 11, 2006 

Date Adopted 

IACUC Committee 

2.0 

December 11, 2020 

Review 

Heivilin 

3.0 

June 10, 2024 

Review 

Hicks 

4.0 

June 22,2025 

Review and Editing 

Hicks 

Appendix 1: Guidance on Serious (Reportable) Incidents of Noncompliance 

Through Notice (), Guidance on Prompt Reporting to OLAW under the PHS Policy on Humane Care and Use of Laboratory Animals,  provides the following guidance to institutions on how to determine if an incident requires a formal report to OLAW: 

“A comprehensive list of definitive examples of reportable situations is impractical. Therefore, the examples below do not cover all instances but demonstrate the threshold at which OLAW expects to receive a report. Institutions should use rational judgment in determining what situations meet the provisions of IV.F.3 and fall within the scope of the examples below and consult with OLAW if in doubt. 

Examples of Reportable Situations: 

  1. Conditions that jeopardize the health or well-being of animals, including natural disasters, accidents, and mechanical failures, resulting in actual harm or death to animals; 
  2. Conduct of animal-related activities without appropriate IACUC review and approval; 
  3. Failure to adhere to IACUC-approved protocols; 
  4. Implementation of any significant change to IACUC-approved protocols without prior IACUC approval as required by IV.B.7.; 
  5. Conduct of animal-related activities beyond the expiration date established by the IACUC (note that a complete review under IV.C is required at least once every three years); 
  6. Conduct of official IACUC business requiring a quorum (full Committee review of an activity in accord with IV.C.2 or suspension in accord with IV.C.6) in the absence of a quorum; 
  7. Conduct of official IACUC business during a period of time that the Committee is improperly constituted; 
  8. Failure to correct deficiencies identified during the semiannual evaluation in a timely manner; 
  9. Chronic failure to provide space for animals in accordance with recommendations of the Guide unless the IACUC has approved a protocol-specific deviation from the Guide based on written scientific justification; 
  10. Participation in animal-related activities by individuals who have not been determined by the IACUC to be appropriately qualified and trained as required by IV.C.1.f; 
  11. Failure to monitor animals post-procedurally as necessary to ensure well-being (e.g., during recovery from anesthesia or during recuperation from invasive or debilitating procedures); 
  12. Failure to maintain appropriate animal-related records (e.g., identification, medical, husbandry); 
  13. Failure to ensure death of animals after euthanasia procedures (e.g., failed euthanasia with CO2); 
  14. Failure of animal care and use personnel to carry out veterinary orders (e.g., treatments); or 
  15. IACUC suspension or other institutional intervention that results in the temporary or permanent interruption of an activity due to noncompliance with the Policy, Animal Welfare Act, the Guide, or the institution’s Animal Welfare Assurance.  

OLAW recognizes that there may be levels of morbidity and mortality in virtually any animal-related activity, including those associated with the care and use of animals in research, testing, and teaching that are not the result of violations of either the Policy or the Guide. OLAW offers the following examples of situations which may not meet the threshold for reporting, based on consideration of the circumstances by the IACUC. 

Examples of Situations NOT Normally Required to be Reported: 

  1. Death of animals that have reached the end of their natural life spans; 
  2. Death or failures of neonates to thrive when husbandry and veterinary medical oversight of dams and litters was appropriate; 
  3. Animal death or illness from spontaneous disease when appropriate quarantine, preventive medical, surveillance, diagnostic, and therapeutic procedures were in place and followed; 
  4. Animal death or injuries related to manipulations that fall within parameters described in the IACUC-approved protocol; or 
  5. Infrequent incidents of drowning or near-drowning of rodents in cages when it is determined that the cause was water valves jammed with bedding (frequent problems of this nature, however, must be reported promptly along with corrective plans and schedules).”